Our regulatory experts offer guidance on drug development and regulatory strategy, ensuring your organization navigates the regulatory landscape effectively. Detailed analysis reports outlining regulatory pathways, risk assessments, and strategic recommendations tailored to your organization's needs.

We assist clients in obtaining and maintaining wholesale dealers' licenses and parallel importers' licenses across the EU, facilitating compliant distribution. License applications, compliance audits, and regulatory correspondence.

Our dynamic team offers tailored pharmacovigilance services, ensuring compliance with safety monitoring requirements and enhancing patient safety. Pharmacovigilance plans, adverse event reporting documentation, and risk management plans.

Our outsourcing services provide flexible regulatory support for short or long-term projects, ensuring continuity during periods of transition or resource gaps. Outsourcing agreements, project timelines, and interim management reports.

We prepare comprehensive Chemistry, Manufacturing, and Controls (CMC) dossiers, IMPDs, and CPPs, ensuring regulatory compliance for product development. CMC regulatory submissions, manufacturing process descriptions, and quality control documentation.

We prepare comprehensive submission documents tailored to specific regulatory requirements, facilitating market access in different regions. Country-specific dossier compilations, regulatory submission forms, and linguistic translations.

With extensive global experience, we facilitate interactions with regulatory agencies worldwide, ensuring compliance with local regulations. Agency correspondence records, regulatory filing documentation, and global regulatory strategy reports.

Our team manages communication with regulatory agencies on behalf of your company, ensuring timely responses and compliance with requirements. Regulatory correspondence logs, agency meeting minutes, and submission cover letters.

Our experienced team provides support throughout the merger, divestment, and acquisition process, ensuring regulatory compliance and smooth transitions. Regulatory integration plans, divestment agreements, and acquisition due diligence reports.

We conduct regulatory due diligence to identify risks and gaps, facilitating informed decision-making for mergers, acquisitions, and partnerships. Due diligence reports, risk assessments, and gap analysis summaries.

Our panel of certified Qualified Persons (QPs) offers expertise for short and long-term assignments, ensuring compliance with regulatory requirements. QP appointment documentation, batch release reports, and regulatory compliance certificates.

Our skilled teams offer tailored training sessions on various regulatory topics, empowering your staff with regulatory knowledge and expertise. Training materials, presentations, and regulatory compliance manuals.

We provide comprehensive support to prepare companies for Brexit scenarios, minimizing regulatory disruptions and ensuring continuity. Brexit impact assessments, contingency plans, and regulatory compliance checklists.

We assist in identifying key challenges and technical questions, facilitating discussions with regulatory authorities to ensure regulatory compliance. Scientific advice meeting summaries, regulatory correspondence records, and technical briefing documents.

We leverage our experience to develop Standard Operating Procedures (SOPs) across regulatory and quality areas, ensuring consistency and compliance. SOP manuals, process flowcharts, and SOP training modules.

Our in-house capabilities support the electronic submission of regulatory documents, streamlining the submission process. eCTD-compliant dossier compilations, electronic submission-ready documents, and validation reports.

Patient readability testing ensures comprehension of informational materials, enhancing patient safety and compliance. User testing protocols, readability test results, and revised patient information leaflets.

With our representation services, companies outside the EU can seamlessly navigate regulatory processes within the region. Representation agreements, regulatory liaison documentation, and compliance reports for non-EU sponsors.

We provide accurate and compliant labeling, Summary of Product Characteristics (SmPCs), and medical writing services to meet regulatory requirements. Labeling templates, SmPC drafts, patient information leaflets, and clinical study reports.

We manage all aspects of Marketing Authorization Applications (MAA), from initial submissions to post-approval support, ensuring compliance with regulations throughout the product lifecycle. Documentation including regulatory submissions, variations, and renewal applications, as well as ongoing compliance reports and updates.

Our team handles the preparation and submission of Clinical Trial Applications (CTA) to Health Authorities and Ethics Committees, ensuring timely approvals. CTA submissions, protocol summaries, informed consent forms, and regulatory correspondence.